About this opportunity
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Roche Diagnostics
Job Purpose
Serves as a strategic business partner to commercial and operational teams, driving regulatory market access and registration excellence across Hong Kong and Macau. Engages proactively with health authorities and industry associations to shape favorable regulatory pathways, ensuring Roche Diagnostics maintains its IVD market leadership while navigating evolving regulatory landscapes.
Responsibility & Accountability
Regulatory Affairs:
Regulatory Strategy & Market Access: Formulate and execute comprehensive regulatory strategies for Hong Kong and Macau to secure timely product registrations, approvals, and lifecycle maintenance aligned with organizational goals.
External Engagement & Policy Intelligence: Monitor, interpret, and assess regulatory environment changes; maintain proactive dialogue with local health authorities and industry associations to support favorable regulatory frameworks and review pathways.
Subject matter expertise in regulatory submission: Lead the designated product portfolios, work closely with the RA and cross teams to provide regulatory guidance to resolve complex submission and compliance challenges.
Compliance & Quality Assurance: Ensure local operations adhere to global quality standards, IVD/medical device regulations, and local SOPs; oversee quality management tasks, audit readiness, promotional material reviews, and internal compliance training.
Cross-Functional Partnership: Collaborate closely with local commercial, marketing, quality, regional, and global stakeholders to ensure regulatory alignment throughout the product lifecycle and enhance cross-team operational efficiency.
Requirements:
Education:
B.S. degree in Biomedical Science, Life Sciences, or related field.
Experience:
4-5 years of health-related regulatory experience
Team management experience preferred
Competency:
Strong understanding of regulatory environments and requirements of HK, Macau, China, EU, and US authorities.
In-depth knowledge of Medical Device and IVD regulations, international, quality standards (e.g. ISOs) & guidelines
Strategic thinking with the ability to simplify complexity and challenge the status quo
Business acumen & communication: Strong cross-functional communication skills to translate complex regulatory requirements into commercial solutions.
Digital & process proficiency: Hands-on capability with digital tools and automation to establish tracking systems and dashboards.
Policy Advocacy: Strong aptitude for external advocacy, policy shaping, and simplifying complex regulatory issues.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 76 comparable Senior Regulatory Affairs roles across 35 biopharma companies.
Salary context
31 of 76 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 76 comparable roles
+ 10 more countries
Seniority mix
76 of 76 peers have a known seniority level
Therapeutic area mix
6 of 76 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.